United States Department of Agriculture 

Agricultural Marketing Service

Federal Grain Inspection Service

Criteria & Specifications January 1, 2023

Distribution: Industry Originating Office: Technology and Science Division

Design Criteria and Test Performance Specifications for Quantitative Ochratoxin A Test Kits

Contents

1. PURPOSE AND SCOPE ............................................................................................................................................ 2

2. SUMMARY OF TEST KIT EVALUATION PROCESS............................................................................................ 2

3. PROGRAM CONTACT INFORMATION................................................................................................................... 2

4. FEE FOR TEST KIT EVALUATION .......................................................................................................................... 3

5. DEFINITIONS ............................................................................................................................................................... 3

6. DESIGN AND PERFORMANCE REQUIREMENTS .............................................................................................. 3

7. MANUFACTURER’S NOTIFICATION RESPONSIBILITIES................................................................................. 9

8. REVISION HISTORY................................................................................................................................................... 9

Appendix A. Protocol & Notification Agreement Statement.........................................................................................10

Appendix B. Guidelines for Test Kit Instructions ...........................................................................................................11

Appendix C. Commodity List ............................................................................................................................................12

Appendix D. Test Kit Evaluation Submission Form ......................................................................................................14

The U.S. Department of Agriculture (USDA) prohibits discrimination in its programs on the basis of race, color, national 

origin, sex, religion, age, disability, political beliefs, and marital or familial status. (Not all prohibited bases apply to all 

programs.) Persons with disabilities who require alternate means for communication of program information (Braille, large 

print, audiotape, etc.) should contact USDA’s TARGET Center at (202) 720-2600 (voice and TDD).

To file a complaint, write to the USDA, Office of Civil Rights, Room 326-W, 1400 Independence Avenue, SW, Washington, DC 

20250-9410, or call (202) 720-5964 (voice and TDD). USDA is an equal employment opportunity employer.
Design Criteria and Test Performance Specifications 

for Quantitative Ochratoxin A Test Kits

Effective January 1, 2023

Page 2 

1. PURPOSE AND SCOPE

The United States Department of Agriculture’s Federal Grain Inspection Service (FGIS) 

provides official mycotoxin testing services throughout the United States for domestic and 

export grains, oilseeds, and processed-grain commodities. Official testing services are 

available for aflatoxins, deoxynivalenol, fumonisins, ochratoxin A, and zearalenone. Testing at 

field locations requires rapid, simple, inexpensive, and accurate methods to effectively assess 

the quality of U.S. grain. An important part of quality assurance for official mycotoxin testing is 

the Mycotoxin Test Kit Evaluation (MTKE) Program, through which FGIS evaluates and 

certifies the conformance of quantitative rapid mycotoxin test methods to specific criteria. Only 

rapid test kits having FGIS certification are approved for official mycotoxin testing. Updated 

test kit design criteria and performance specifications for quantitative ochratoxin A test kits are 

covered herein. These requirements are effective January 1, 2023. 

NOTE: Until January 1, 2024, applicants may submit test kits for evaluation under the 

previous requirements issued in June 2018. Certificates issued under the June 2018 

requirements will expire one year from the date of issuance. For a copy of the previous 

requirements, contact the MTKE Program by email at MTKE.Program@usda.gov. 

2. SUMMARY OF TEST KIT EVALUATION PROCESS

FGIS establishes design criteria and performance specifications that mycotoxin test kits must 

meet to be considered for use in official inspection. Test kit manufacturers may submit a test 

kit for evaluation by FGIS staff. Submission packets are reviewed by FGIS staff in order of 

receipt. The submission packet must include all documentation needed to demonstrate that the 

test kit meets the established FGIS design criteria and performance specifications. Incomplete 

submissions, submission not conforming to FGIS requirements, and submissions containing 

excessive errors will be rejected. If the submission is accepted, arrangements for FGIS analyst 

training and performance verification will be made with the applicant. The FGIS analysts that 

conduct performance verification testing will be trained in the operation of the test kit by the 

applicant. A maximum of two analysts from the test kit manufacturer may participate in the 

performance verification.

If the test kit meets all design and performance requirements, FGIS issues a Certificate of 

Conformance (COC) stating that the test kit has met the criteria. Upon issuance of the official 

test kit instructions, the test kit may be used for official inspection. The COC will be valid for 

three years from its date of issuance. Renewal of a COC requires a full submission and 

evaluation.

If the test kit fails to meet all of the criteria specified herein, the test kit can be resubmitted after 

the manufacturer has identified and resolved the root cause of the failure. When the test kit is 

resubmitted, the applicant must state the root cause and corrective action that was taken to 

bring the test kit into conformance with FGIS requirements, and a new data packet must be 

submitted. 

3. PROGRAM CONTACT INFORMATION

Send submission packets via email to MTKE. Program@usda.gov. For questions and 

comments regarding mycotoxin test kit evaluation, contact the Mycotoxin Test Kit Evaluation 

Program at MTKE.Program.@usda.gov. 
Design Criteria and Test Performance Specifications 

for Quantitative Ochratoxin A Test Kits

Effective January 1, 2023

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4. FEE FOR TEST KIT EVALUATION

FGIS will assess a fee for evaluating a test kit, including all documentation reviews. Payment is 

expected within 30 days of the invoice date.

5. DEFINITIONS

Applicant. The manufacturer of the test kit under evaluation.

Fortified Samples. Samples to which a known amount of ochratoxin A was previously added 

using a standard solution.

Lower Conformance Limit. The lowest concentration at which the test kit has demonstrated 

acceptable quantitation of ochratoxin A according to FGIS requirements. Submitted test kits 

must have a lower conformance limit (LCL) of 5.0 parts per billion (ppb). 

Upper Conformance Limit. The highest concentration at which the test kit has demonstrated 

acceptable quantitation of ochratoxin A according to FGIS requirements. Submitted test kits 

must have an upper conformance limit (UCL) of at least 100 ppb ochratoxin A. Submissions 

with a desired UCL of greater than 100 ppb must be accompanied by additional performance 

data from the applicant at this level, and the test kit must pass a FGIS performance verification 

study at the proposed limit.

Range of Conformance. The concentration range for which a test kit conforms to FGIS 

accuracy requirements. This range is bracketed by the upper and lower conformance limits. 

The minimum range of conformance required by FGIS for quantitative ochratoxin A test kits is 

5.0 – 100 ppb.

Range of Quantitation. The concentration range associated with a single analysis. A test kit 

may have more than one range of quantitation if additional dilutions, reader calibrations, and 

analyses are needed to cover the range of conformance.

Test Kit. A commercially packaged system of the principal or key components of an analytical 

method used to determine the presence of ochratoxin A in specified matrices. Test kits include 

directions for their use and are self-contained, complete analytical systems; however, they may 

require supporting supplies and equipment. The key components frequently represent 

proprietary items that may be available only from the manufacturer of the test kit.

6. DESIGN AND PERFORMANCE REQUIREMENTS

a. Grinding and Homogenizing Sample Materials

All commodities used in the performance studies must be ground so that at least 95% 

passes through a U.S. Standard No. 20 sieve and mixed thoroughly to ensure 

homogeneity prior to removing samples for testing.

b. Sample Storage

Sample materials must be stored in sealed containers at ≤ 8 °C, and refrigerated 

samples must be allowed to reach room temperature before use.
Design Criteria and Test Performance Specifications 

for Quantitative Ochratoxin A Test Kits

Effective January 1, 2023

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c. Preparation of Reference Materials

A validated analytical reference method, preferably the FGIS method, must be used for 

determining the ochratoxin A concentration in all naturally contaminated materials and 

materials used to prepare fortified samples that are used in the performance studies. 

The applicant must state what analytical method was used to certify the reference 

materials. If a method other than the current FGIS reference method is used, a copy of 

the method instructions and validation report or literature reference must be supplied by 

the applicant. This method must have performance characteristics (accuracy and 

precision) that are equivalent to the FGIS reference method. Determination of method 

equivalence resides with the applicant. The FGIS reference method is available upon 

request.

The ochratoxin A concentration in each naturally contaminated reference material must 

be determined by analyzing the minimum of twenty-one samples (25.0 ± 0.2 g each) 

across three batches (seven samples in each batch) using the FGIS reference method 

or equivalent method. For use of a material in the test kit trials, the mean ochratoxin A

concentration must be within ± 15% of the target concentration.

Ochratoxin A-contaminated materials produced through fungal inoculation and growth 

under laboratory conditions may be used in place of naturally contaminated materials. A 

relevant fungal species and strain isolated from the Continental United States must be 

used for producing the contaminated commodity. Although inoculation is allowed for 

generating contaminated samples, the test kit will be expected to meet FGIS 

performance criteria when determining ochratoxin A on any naturally contaminated 

grain or processed-grain commodity sample originating in the United States.

d. Preparation of Standard Solutions

The purity of the neat ochratoxin A standards must be ≥ 98%. A certificate of analysis 

from the supplier of each neat standard must be provided in the submission packet.

The concentration of the ochratoxin A in standard solutions must be determined by UV 

spectrophotometry as specified in the FGIS reference method.

e. Conditions of Analysis

All analyses must be conducted at room temperature (i.e., 20 – 24 °C) unless specified 

otherwise.

When generating test kit data for submission, all samples must be labeled with a code 

and fully randomized so that the analyst conducting the test cannot know the level of 

analyte. Furthermore, the same person performing the analyses must not prepare the 

test samples.

f. Written Instructions for Test Kit Use

The applicant must provide complete, written instructions for use of the test kit that 

accurately reflect the procedures followed to generate the data in the submission. 
Design Criteria and Test Performance Specifications 

for Quantitative Ochratoxin A Test Kits

Effective January 1, 2023

Page 5 

These instructions must be formatted following the guidelines in Appendix B. FGIS will 

follow these written instructions during training and when verifying test kit performance.

g. Multiple Procedures 

A single, well-defined, analytical method will be evaluated for each submission. Multiple 

procedures, such as options for the use of blending vs. shaking for sample extraction or 

filtration vs. centrifugation for sample clarification, require a full data submission for 

each procedure; each procedure will be evaluated by FGIS. Other instances of multiple 

procedures may require a full data submission packet and evaluation for each 

procedure depending on the significance of the variation. FGIS will determine the need 

of a separate evaluation on a case-by-case basis taking into consideration the possible 

effect of procedural variation and its benefit to the official inspection system. Prior to test 

kit submission, the MTKE Program should be contacted for further guidance on data 

submission and evaluation requirements in such cases.

h. Time for Completion of Analysis

For a pre-ground sample, the test kit procedure must be capable of generating an 

accurate result across the minimum required range of 5.0 – 100 ppb ochratoxin A in 30 

minutes or less (i.e., time from extraction to final result). If the test kit has a limited 

quantitative range and the need for additional dilution and analysis to cover the 

minimum range of conformance, the 30-minute limit includes all steps needed to 

generate the final result.

i. Significant Figures and Unit of Measurement

The test kit reader (or detector) must display results using at least two significant figures 

in parts per billion (ppb). Test kit results will be evaluated using two significant figures. 

When rounding to two significant figures, the number will be rounded up when the third 

digit is 5 or more. For example, 5.25 ppb would be rounded to 5.3 ppb, and 5.24 ppb 

would be rounded to 5.2 ppb. To avoid rounding error, at least three significant figures 

should be used when performing calculations, and only the calculated result should be 

rounded to two significant figures.

j. Accuracy 

(1) Minimum Required Range of Conformance

The applicant must provide data demonstrating accuracy of the test kit using 

naturally contaminated corn at the targeted concentrations of 5.0, 20, and 100 

ppb ochratoxin A. 

Three analysts must each extract seven separate samples at each concentration 

according to the test kit instructions. Each analyst must use a different 

manufacturing lot for the test kit materials and a different reader. All samples 

must be analyzed as if the concentrations were unknown.
Design Criteria and Test Performance Specifications 

for Quantitative Ochratoxin A Test Kits

Effective January 1, 2023

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At least 95% of the results (20 out of 21) for each concentration level must be 

within the acceptable ranges specified in Table 1. The acceptable range is

determined by the following equation. 

Acceptable Range (ppb) = y� ± 0.02∙RSDmax∙y�

where y� is the mean concentration determined in the reference material 

analyses, and RSDmax is maximum relative standard deviation listed in Table 1

for the target concentration. 

TABLE 1. MAXIMUM ACCETPABLE LIMITS

Ochratoxin A*

(ppb)

RSDmax

(%)

Standard Deviation 

(ppb)

Acceptable Range 

(ppb)

5.0 20 1.0 3.0 – 7.0

20 20 4.0 12 – 28

100 20 20 60 – 140

*± 15%

(2) Extended Range of Conformance

For an UCL above 100 ppb ochratoxin A, the applicant is required to provide data 

demonstrating the test kit’s capability for meeting the performance requirements 

at the proposed UCL. The applicant must also provide the analytical procedure 

used to generate the supporting data. The use of naturally contaminated 

materials to generate supporting data is preferred; however, fortified samples are 

acceptable. The FGIS reference method or equivalent must be used to 

characterize the naturally contaminated material as described previously. The 

standard solution used for fortification of additional commodity samples must be 

prepared according to Section 6.d. After fortification, samples must be left open 

in a fume hood for approximately 30 minutes to allow the solvent to evaporate 

prior to extraction.

Three analysts must each extract seven separate samples (50.0 ± 0.2 g each) at 

the UCL according to the test kit instructions. Each analyst must use a different 

manufacturing lot for the test kit materials and a different reader. All samples 

must be analyzed as if the concentrations were unknown. At least 95% of the 

results (20 out of 21) must be within the range specified in Table 2.

TABLE 2. MAXIMUM ACCEPTABLE LIMIT FOR UCL

Ochratoxin A

(ppb)

RSDmax

(%)

Standard Deviation

(ppb)

Acceptable Range

(ppb)

UCL > 100 20 0.20·UCL UCL ± 0.40·UCL

(3) Multiple Ranges of Quantitation

Additional data must be submitted when a test kit uses multiple ranges of 

quantitation.

The applicant must provide data demonstrating accuracy of the test kit using 21 

samples (50 ± 0.2 g each) of corn naturally contaminated at the concentration 
Design Criteria and Test Performance Specifications 

for Quantitative Ochratoxin A Test Kits

Effective January 1, 2023

Page 7 

level where the two ranges meet following each protocol for extraction and 

analysis consistent with Section 6.j.(1). Both analysis procedures must be tested 

at this level. The same set of extracts should be used to test the procedure for 

each range of quantitation. Twenty of the 21 results must be within the 

acceptable range for each analysis procedure. The Maximum RSD is 20 for all 

concentrations.

(4) Additional Commodities

Application for approval of additional commodities can be made at the time of 

original submission or after the test kit has been approved. The list of acceptable 

commodities is found in Appendix C. Contact the MTKE Program for possible 

incorporation of additional commodities not included in this list. The applicant 

must provide the additional commodity name and definition.

Applicants must provide data in accordance with the following guidelines for each 

additional commodity and the specific procedures followed for analysis. Fortified 

samples can be used to generate the supporting data; however, the test kit will 

also be expected to adhere to the accuracy requirements for naturally 

contaminated samples. 

The standard solution used for fortification of additional commodity samples must 

be prepared according to Section 6.d. After fortification, samples must be left 

open in a fume hood for approximately 30 minutes to allow the solvent to 

evaporate prior to extraction. FGIS may verify performance of the test kit using 

fortified or naturally contaminated samples.

Uncontaminated (blank) samples of each additional commodity must be ground 

with a mill so that at least 95% of the material passes through a U.S. Standard 

No. 20 sieve. Ground portions must be mixed to ensure homogeneity and divided 

in a manner to maintain sample representativeness. A description of the specific 

equipment and procedures used in grinding, mixing, sieving processes, and 

dividing must be provided.

For each additional commodity, five fortified samples must be tested at each 

targeted level of 5.0, 20, and 100 ppb ochratoxin A. For an UCL limit above 100 

ppb, five samples at the proposed UCL must also be included in the study.

One analyst must extract all samples according to the test kit instructions. For 

each additional commodity, the analyst must analyze one aliquot of each extract.

All of the results must be within the ranges specified for the fortification levels 

according to Table 1 and Table 2.

k. Hazardous Materials and Waste

Use of the test kit must not expose employees, without access to fume hood or 

respirator, to toxic or hazardous substances beyond OSHA Standards specified in 29 

CFR. The test kit must not require special waste disposal (e.g., special waste disposal 

includes all radioactive material, P-listed hazardous waste, or hazardous waste listed for 
Design Criteria and Test Performance Specifications 

for Quantitative Ochratoxin A Test Kits

Effective January 1, 2023

Page 8 

its toxicity characteristic as defined in 40 CFR). The applicant must attest that the test 

kit meets these requirements. Safety Data Sheets (SDS) must be provided for all 

materials used in the test kit.

l. Sensitivity to Electromagnetic Fields

Electronic equipment used with the test kit must not be sensitive to electromagnetic 

fields spanning a frequency of 800 MHz to 6 GHz and an intensity of 1.0 volts/ meter to 

5.0 volts/meter. Electric fields must not cause the equipment display to be corrupted or 

otherwise affect readings during the test. The applicant must provide a statement of 

certification from an accredited laboratory verifying the equipment meets these 

requirements. Laboratories conducting the electromagnetic study must be accredited by 

a signatory of the International Laboratory Accreditation Cooperation Mutual 

Recognition Arrangement. Tests must be performed according to the guidelines in 

Electromagnetic Compatibility (IEC 61000-4-3; International Electrotechnical 

Commission, Geneva, Switzerland).

m. Temperature Sensitivity

Wheat that is naturally contaminated with ochratoxin A at 20 ppb must be used in the 

temperature sensitivity study. Seven samples (50.0 ± 0.2 g each) must be extracted, 

and one analysis of each extract must be performed at each of three temperature 

conditions (i.e., 18 °C, 24 °C, and 30 °C) to yield seven analyses at each temperature. 

Extracted samples must be protected from light during this study. All test materials (i.e., 

extracts and test kit components) must be allowed to equilibrate to the targeted 

temperature for one hour using an environmental chamber prior to analysis. At least 

95% of the results (20 out of 21) must be within the range as specified in Table 1.

n. Shelf Life

The applicant must provide a shelf life label statement and supporting data under the 

recommended storage conditions for all materials and reagents used in their tests. In 

addition, the applicant must provide the procedure followed for generating and 

analyzing the stability data. Real-time data is preferred for supporting stability claims; 

however, accelerated aging based on the Arrhenius equation may be used. The stability 

data must demonstrate conformance to all applicable criteria in this document.

o. FGIS Performance Verification

After acceptance of a submission, the applicant will be contacted to arrange for training 

of the analysts who will conduct the FGIS performance verification. The training allows 

the applicant to provide hands-on training to the FGIS analysts for the sample

preparation and equipment operation procedures. The analysts will receive up to one 

day of training in the use of each test kit by the applicant or designee. A maximum of 

two analysts from the test kit manufacturer may participate in the performance 

verification. The applicant is required to provide all equipment and supplies needed to 

complete the training and FGIS performance verification. Any naturally contaminated 

materials used for the performance verification will be characterized as specified in 

Section 6.c using the current FGIS reference method.
Design Criteria and Test Performance Specifications 

for Quantitative Ochratoxin A Test Kits

Effective January 1, 2023

Page 9

(1) Minimum Required Range of Conformance

FGIS will verify the test kit’s performance following the procedure as described in 

Section 6.j.(1) at the targeted levels of 5.0 and 100 ppb ochratoxin A.

(2) Extended Range of Conformance

For an UCL greater than 100 ppb, FGIS will verify the test kit’s performance 

following the procedure as described in Section 6.j.(2).

7. MANUFACTURER’S NOTIFICATION RESPONSIBILITIES

Manufacturers holding a COC must notify the MTKE Program in writing when any changes or 

alterations are made to the test kit, including reagents, shelf life of test kit materials, equipment 

used in the test kit, software or calibration revisions, or any part of the analytical method. 

Alterations to a test kit will be evaluated by FGIS for significance and may require another full 

FGIS performance verification. Failure to notify FGIS of such changes will serve as grounds for 

immediate cancellation of the COC. Changes to the kit packaging, brochure, or other 

marketing information are exempt from this requirement.

8. REVISION HISTORY

Revision 2 (January 1, 2023)

• Added allowance for up to two analysts from manufacturer to participate in FGIS 

performance verification.

• Added requirement for three readers to be used. 

• Removed 3-month wait period for resubmitting a test kit that failed to meet the 

performance criteria.

• Removed program leader phone number and updated email.

• Updated laboratory accreditation requirements for the electromagnetic field 

sensitivity tests to include other accreditation bodies besides NIST.

• Placed appendices after Revision History section.

• Added examples of multiple ranges of quantitation for clarification of data 

submission requirements. 

Revision 1 (June 1, 2018)

• Added Corn Gluten Meal and Wheat Gluten to Appendix C: Commodity List.

Revision 0 (January 1, 2016)

• Original Release
Design Criteria and Test Performance Specifications 

for Quantitative Ochratoxin A Test Kits

Effective January 1, 2023

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Appendix A. Protocol & Notification Agreement Statement

This is to certify that I am an official representative of ________________________________, 

that I fully understand the conditions that FGIS will use to determine if our quantitative 

ochratoxin A test kit marketed under the trade name

___________________________________________ will be given a Certificate of 

Conformance for use in the official inspection system. If issued, the Certificate of 

Conformance will be valid for three years from the date. FGIS monitors the performance of 

all approved test kits and reserves the right to verify the performance of the test kit at 

any time. I understand that if the kit fails to meet the criteria set forth in the performance 

specification document, the Certificate of Conformance will be revoked immediately. I further 

understand that the Certificate of Conformance will expire after three years and the kit must be 

completely re-evaluated to renew certificated status. I accept these conditions and agree to 

abide by the Manufacturer’s Notification Responsibilities provided in this document.

Name Date

Title
Design Criteria and Test Performance Specifications 

for Quantitative Ochratoxin A Test Kits

Effective January 1, 2023

Page 11

Appendix B. Guidelines for Test Kit Instructions

The following section headings and outline format must be used for official test kit instructions. 

In addition to the instructions, FGIS recommends the use of a flow chart to summarize the test 

procedure. The flow chart may be submitted as an appendix. An example of a completed set of 

test kit instructions is available from FGIS upon request. Pictures should be included in the 

written instructions only if necessary.

Section Headings

GENERAL INFORMATION

PREPARATION OF TESTING MATERIALS AND EQUIPMENT

EXTRACTION PROCEDURES

SAMPLE PREPARATION FOR QUANTIFICATION

TEST PROCEDURES SUPPLEMENTAL ANALYSIS

REPORTING AND CERTIFYING TEST RESULTS 

STORAGE CONDITIONS AND PRECAUTIONS 

EQUIPMENT AND SUPPLIES

REVISION HISTORY

FLOW CHARTS

Outline Format

1. XXXXX

Text aligns under the indent level

a. Xxx 

b. Xxx 

(1) Xxx 

(2) Xxx 

(a) Xxx 

(b) Xxx 

1 Xxx 

2 Xxx 

a Xxx 

b Xxx 
Design Criteria and Test Performance Specifications 

for Quantitative Ochratoxin A Test Kits

Effective January 1, 2023

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Appendix C. Commodity List

Commodity

1. Amaranth

2. Barley (with hull, including Malting Barley)

3. Malted Barley (including Malted Barley Flour)

4. Hulled Barley (including Hulless Barley)

5. Pearl or Pearled Barley (including Quick Pearl Barley)

6. Barley Grits

7. Barley Flakes

8. Buckwheat

9. Corn (including Dent or Field Corn, Corn Meal, Corn Flour, Cracked Corn, Corn Grits or 

Polenta, and Corn screenings)

10. Corn Bran

11. Corn Germ

12. Corn Germ Meal

13. Corn Gluten Feed (including Corn Gluten Feed Meal)

14. Corn Gluten Meal

15. Flaking Corn Grits

16. Corn Starch

17. Corn/Soy Blend

18. Corn/Soy Blend Plus

19. Corn/Soy/Whey Blend

20. Popcorn

21. Super Cereal Plus

22. Sweet Corn

23. Condensed Distillers Solubles

24. Cottonseed Meal

25. Cottonseed Hulls

26. Whole Cottonseed (including Linted Cottonseed and Delinted Cottonseed)

27. Distillers Dried Grain

28. Distillers Dried Grain w/Solubles

29. Hominy (including Hominy Grits)

30. Hominy Feed
Design Criteria and Test Performance Specifications 

for Quantitative Ochratoxin A Test Kits

Effective January 1, 2023

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Commodity

31. Millet

32. Oats (Whole Oats with Hull)

33. Oat Groats

34. Oat Bran

35. Rapeseed

36. Rapeseed Meal

37. Brown Rice

38. Milled Rice (including Brewer’s Rice and Glutinous Rice)

39. Rough Rice

40. Rice Bran

41. Wild Rice

42. Rye (or Rye Berries, including Whole Grain Rye Flour, Rye Meal, Cracked Rye, and 

Rye Chops)

43. White Rye Flour

44. Rye Flakes

45. Wheat (including Whole Grain Wheat Flour, Wheat Middlings, Wheat Red Dog, Wheat

Flour 2nd Clear, and Wheat Screenings)

46. White Wheat Flour

47. Wheat Bran (including Wheat Bran Aleurone)

48. Wheat Gluten

49. Sorghum

50. Soybean (including Whole Soybean and Full-Fat Soy Flour)

51. Defatted Soy Flour

52. Soybean Meal

53. Soybean Hulls

54. Triticale
Design Criteria and Test Performance Specifications 

for Quantitative Ochratoxin A Test Kits

Effective January 1, 2023

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Appendix D. Test Kit Evaluation Submission Form

The applicant must fill out the submission form and provide it along with the submission 

packet. The information provided in the submission form will be used in creating the certificate 

if the test kit meets all FGIS requirements; therefore, it is imperative that the form be filled out 

correctly. A fillable version of this form is available on the AMS website.

Contact Information

Applicant (i.e., test kit manufacturer)

Street Address

City, State, Zip Code

Contact Person

Phone Number

Email Address

Billing Address

(if different than manufacturer’s address)

City, State, Zip Code

Test Kit Information

Test Kit Name

Product Identification Number

Test Method Format

Reader Name

Reader Model or Identification Number
Design Criteria and Test Performance Specifications 

for Quantitative Ochratoxin A Test Kits

Effective January 1, 2023

Page 15

Test Kit Information

Detection Method

Upper Conformance Limit

Additional 

Commodities (list in 

alphabetical order)
Design Criteria and Test Performance Specifications 

for Quantitative Ochratoxin A Test Kits

Effective January 1, 2023

Page 16

Design Criteria and Performance Specification Check List Initials

The test kit meets the performance requirements and submission packet components 

are included.

Time for completion of analysis ≤ 30 minutes

FGIS reference method or equivalent used for reference analyses (validation report or 

literature reference provided if GIPSA reference method not used)

Accuracy study for naturally contaminated wheat from 5.0 – 100 ppb

Additional accuracy data for optional extension of upper limit of conformance above

100 ppb ochratoxin A in wheat

Data supporting accuracy of multiple ranges of quantitation

Additional commodities – accuracy data; sample preparation and analytical procedure 

is described for each additional commodity (including grinding procedure); type of 

reference material is given (naturally-contaminated or standard-solution fortified)

Use of the test kit does not expose the employees to toxic or hazardous substances

higher than OSHA Standards per 29 CFR when used without a fume hood or respirator.

Use of the test kit does not generate radioactive waste, P-listed hazardous waste, or

hazardous waste listed for its toxicity characteristic as defined in 40 CFR

Safety Data Sheets (SDS)

Reader electromagnetic field study certification statement (renewals exempt if same reader)

Temperature sensitivity study

Shelf life study

Certificates of analysis for reference materials

Written test kit instructions (provided as Microsoft Word document)

Method flow chart is included (optional)

Protocol & Notification Agreement Statement signed by applicant

Comments: